Trial record 13 of 468 for:    Open Studies | "Renal Dialysis"

Investigating the Effects of Exercise on Physiological Changes and Toxin Removal in Hemodialysis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National University Hospital, Singapore
Sponsor:
Collaborator:
National University, Singapore
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01674153
First received: August 23, 2012
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

Hemodialysis is a life-saving treatment for end stage renal disease patients. The chief aims of hemodialysis are solute and fluid removal. Solute removal is associated with outcome of dialysis patients. Intra-dialytic exercise has been found to improve the toxin removal and it is suggested that exercise increases the cardiac output, thus increases the blood flow to lower extremities. This leads to increased toxin removal from low blood flow regions. On the other hand, exercise can possibly dilate the vasculature and decrease the compartmental resistance. In this study, the investigators aim to investigate the exercise induced physiological changes which enhances the toxin removal. This information combined with patient specific mathematical models will encourage clinicians to opt for Optimal intra-dialytic exercise protocol. On the other hand, Hemodiafiltration is widely accepted renal replacement therapy for improved toxin removal. Hence, we intend to compare the toxin removal outcome for standalone Hemodiafiltration and intra-dialytic exercise in conventional hemodialysis.


Condition Intervention
Renal Dialysis
Procedure: Intra-dialytic exercise

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Multi Protocol Investigation to Compare the Effects of Intra-dialytic Exercise on Physiological Changes and Toxin Removal in Maintenance Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Quantify toxin removal [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measure/estimate amount of toxin(s) removed and quantify corresponding physiological changes


Secondary Outcome Measures:
  • Compare exercise regimen with HDF [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Compare amount of toxin removed for conventional hemodialysis (HD), HD with intra-dialytic exercise, and hemodiafiltration


Estimated Enrollment: 15
Study Start Date: August 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HD-Exercise-HDF
Prescribe intra-dialytic exercise of three bouts in 4 hours dialysis session.
Procedure: Intra-dialytic exercise
Perform intra-dialytic exercise of three bouts in 4 hours dialysis session. Each patient will perform exercise on Monark 881E rehab trainer (widely used in routine dialysis settings). The exercise intensity will be prescribed based on achievement of 50% of maximum heart rate for each recruited subject.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients male or female (Age > 21 years)
  • Minimum dialysis vintage of 6 months
  • Stable on hemodialysis
  • Minimum Hemoglobin level of 10 g/dL
  • Blood access capable of delivering the blood flow rate greater than 250 mL/min
  • Preserved left ventricular ejection fraction (>50%) on prior imaging study
  • Able to complete a 6min-walk-test without abnormal physiological response, excessive fatigue, or musculoskeletal discomfort

Exclusion Criteria:

  • History of recurring or persistent hypotension in past 3 months
  • Pregnant woman
  • Severely Hypertensive patients (SBP > 180 mmHg and/or DBP > 115 mmHg)
  • History of recent myocardial infarction or unstable angina (within past 6 months)
  • Significant valvular disease, i.e. severe aortic stenosis and moderate-severe mitral regurgitation.
  • Patients with end stage organ disease e.g. COPD, recent or debilitating CVA
  • Patient with recent stroke (within past 6 months)
  • Anemic patients
  • History of known arrhythmia
  • Participation in another clinical intervention trial
  • Moderate to severe osteoarthritis of knee(s)
  • Unable to consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674153

Contacts
Contact: Titus Lau, MD +65 6772 4388 ext 4388 titus_lau@nuhs.edu.sg
Contact: Vaibhav Maheshwari, B.Tech. +65 9354 1493 vmaheshwari@nus.edu.sg

Locations
Singapore
Dialysis Center, National University of Singapore Recruiting
Singapore, Singapore, 119074
Contact: Titus Lau, MD    +65 6772 4388    titus_lau@nuhs.edu.sg   
Principal Investigator: Titus Lau, MD         
Sponsors and Collaborators
National University Hospital, Singapore
National University, Singapore
Investigators
Principal Investigator: Titus Lau, MD National University Hospital, Singapore
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01674153     History of Changes
Other Study ID Numbers: DSRB - 2011/01942, NKFRC/2011/01/06
Study First Received: August 23, 2012
Last Updated: April 1, 2014
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Intra-dialytic exercise
Toxin removal
Hemodiafiltration
Inter-compartmental resistance
Cardiac output

ClinicalTrials.gov processed this record on September 30, 2014